Skeletal Metastasis Registry

Metastatic Bone Tumor Clinical Trial

Official title:

The International Skeletal Metastasis Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05058014
• Other study ID #: SIB1802
• Secondary ID: IRB00157231
• Status: Recruiting
• Start date: August 16, 2018
• Est. completion date: August 16, 2025

Study information

• Verified date: October 2023
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: Vaishali Laljani
• Phone: 410-502-2160
• Email: vparikh2[@]jhmi.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is a prospective, observational study designed to contribute data from patients with symptomatic metastatic bone disease treated at Sibley Memorial Hospital and Johns Hopkins Medicine to an international registry hosted by the Swedish Regional Cancer Centrum in Stockholm, Sweden. This protocol supports a worldwide effort to collect and store information from patients treated for symptomatic bone metastases within the International Skeletal Metastasis Registry (ISMR)

Description:

The registry is designed to update a suite of clinical decision-support tools designed for use when treating patients with metastatic bone disease. The models estimate the likelihood of survival at 1, 3, 6, 12, 18, and 24 months post surgery, which in turn, may be used for surgical decision-making.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 16, 2025
• Est. primary completion date: December 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, age 22 or older

• Biopsy-proven or clinically-obvious metastatic bone disease

• Symptomatic bone lesion requiring intervention o Including, not limited to, radiotherapy, cryotherapy, radiofrequency ablation, operative fixation, prosthetic replacement, amputation, or any combination of the above.

Related Conditions & MeSH terms

• Bone Neoplasms
• Metastatic Bone Tumor

Locations

Country	Name	City	State
United States	Johns Hopkins	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Defense Health Programs with the U.S. Army Medical Research and Materiel Command, Murtha Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	OS (in months) calculated from the date of intervention.	Up to 24 Months post surgery
Secondary	Reoperation or retreatment for any reason	Number of participants with reoperation or retreatment for any reason.	Up to 24 24 months post surgery
Secondary	Time to reoperation or retreatment for any reason	Timing of reoperation calculated from the date of intervention.	Up to 24 months post surgery